Invanz Side Effects
Generic Name: ertapenem
Please note - some side effects for Invanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Invanz - for the Consumer
Invanz
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Invanz:
Seek medical attention right away if any of these SEVERE side effects occur when using Invanz:Diarrhea; dizziness; headache; indigestion; nausea; sleeplessness; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; breathing problems; chest pain; fast heartbeat; fever, chills, or sore throat; mental or mood changes (eg, agitation, anxiety, confusion); pain, swelling, or redness at the injection site; seizures; severe or persistent diarrhea; severe stomach cramps or pain; swelling of hands or feet; tremors or abnormal muscle movements; unusual vaginal odor or discharge; white patches in the mouth.
Invanz Side Effects - for the Professional
Invanz
Adults
Clinical studies enrolled 1954 patients treated with ertapenem; in some of the clinical studies, parenteral therapy was followed by a switch to an appropriate oral antimicrobial. Most adverse experiences reported in these clinical studies were described as mild to moderate in severity. Ertapenem was discontinued due to adverse experiences in 4.7% of patients. Table 6 shows the incidence of adverse experiences reported in ≥1.0% of patients in these studies. The most common drug-related adverse experiences in patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).
| Invanz* 1 g daily |
Piperacillin/ Tazobactam* 3.375 g q6h |
Invanz† 1 g daily |
Ceftriaxone† 1 or 2 g daily |
|
| Adverse Events | (N=802) | (N=774) | (N=1152) | (N=942) |
|
||||
| Local: | ||||
| Extravasation | 1.9 | 1.7 | 0.7 | 1.1 |
| Infused vein complication | 7.1 | 7.9 | 5.4 | 6.7 |
| Phlebitis/thrombophlebitis | 1.9 | 2.7 | 1.6 | 2.0 |
| Systemic: | ||||
| Asthenia/fatigue | 1.2 | 0.9 | 1.2 | 1.1 |
| Death | 2.5 | 1.6 | 1.3 | 1.6 |
| Edema/swelling | 3.4 | 2.5 | 2.9 | 3.3 |
| Fever | 5.0 | 6.6 | 2.3 | 3.4 |
| Abdominal pain | 3.6 | 4.8 | 4.3 | 3.9 |
| Chest pain | 1.5 | 1.4 | 1.0 | 2.5 |
| Hypertension | 1.6 | 1.4 | 0.7 | 1.0 |
| Hypotension | 2.0 | 1.4 | 1.0 | 1.2 |
| Tachycardia | 1.6 | 1.3 | 1.3 | 0.7 |
| Acid regurgitation | 1.6 | 0.9 | 1.1 | 0.6 |
| Oral candidiasis | 0.1 | 1.3 | 1.4 | 1.9 |
| Constipation | 4.0 | 5.4 | 3.3 | 3.1 |
| Diarrhea | 10.3 | 12.1 | 9.2 | 9.8 |
| Dyspepsia | 1.1 | 0.6 | 1.0 | 1.6 |
| Nausea | 8.5 | 8.7 | 6.4 | 7.4 |
| Vomiting | 3.7 | 5.3 | 4.0 | 4.0 |
| Leg pain | 1.1 | 0.5 | 0.4 | 0.3 |
| Anxiety | 1.4 | 1.3 | 0.8 | 1.2 |
| Altered mental status‡ | 5.1 | 3.4 | 3.3 | 2.5 |
| Dizziness | 2.1 | 3.0 | 1.5 | 2.1 |
| Headache | 5.6 | 5.4 | 6.8 | 6.9 |
| Insomnia | 3.2 | 5.2 | 3.0 | 4.1 |
| Cough | 1.6 | 1.7 | 1.3 | 0.5 |
| Dyspnea | 2.6 | 1.8 | 1.0 | 2.4 |
| Pharyngitis | 0.7 | 1.4 | 1.1 | 0.6 |
| Rales/rhonchi | 1.1 | 1.0 | 0.5 | 1.0 |
| Respiratory distress | 1.0 | 0.4 | 0.2 | 0.2 |
| Erythema | 1.6 | 1.7 | 1.2 | 1.2 |
| Pruritus | 2.0 | 2.6 | 1.0 | 1.9 |
| Rash | 2.5 | 3.1 | 2.3 | 1.5 |
| Vaginitis | 1.4 | 1.0 | 3.3 | 3.7 |
In patients treated for complicated intra-abdominal infections, death occurred in 4.7% (15/316) of patients receiving ertapenem and 2.6% (8/307) of patients receiving comparator drug. These deaths occurred in patients with significant co-morbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators.
In clinical studies, seizure was reported during study therapy plus 14-day follow-up period in 0.5% of patients treated with ertapenem, 0.3% of patients treated with piperacillin/tazobactam and 0% of patients treated with ceftriaxone.
Additional adverse experiences that were reported with Invanz with an incidence >0.1% within each body system are listed below:
Body as a whole: abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, necrosis, candidiasis, weight loss, facial edema, injection site induration, injection site pain, flank pain, and syncope;
Cardiovascular System: heart failure, hematoma, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, and subdural hemorrhage;
Digestive System: gastrointestinal hemorrhage, anorexia, flatulence, C. difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, and pyloric stenosis;
Nervous System & Psychiatric: nervousness, seizure, tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, and vertigo;
Respiratory System: pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, and voice disturbance;
Skin & Skin Appendage: sweating, dermatitis, desquamation, flushing, and urticaria;
Special Senses: taste perversion;
Urogenital System: renal insufficiency, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, and vulvovaginitis.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with ertapenem, the adverse experience profile was generally similar to that seen in previous clinical trials.
In a clinical study in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of ertapenem 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall adverse experience profile was generally comparable to that observed for ertapenem in previous clinical trials. Table 7 shows the incidence of adverse experiences other than those previously described above for ertapenem, regardless of causality, reported in ≥1.0% of patients in this study.
Adverse Events |
Invanz 1 g (N= 476) |
Cefotetan 2 g(N= 476) |
| Anemia | 5.7 | 6.9 |
| Small intestinal obstruction | 2.1 | 1.9 |
| Cellulitis | 1.5 | 1.5 |
| C. difficile infection or colitis | 1.7 | 0.6 |
| Pneumonia | 2.1 | 4.0 |
| Postoperative infection | 2.3 | 4.0 |
| Urinary tract infection | 3.8 | 5.5 |
| Wound infection | 6.5 | 12.4 |
| Anastomotic leak | 1.5 | 1.3 |
| Seroma | 1.3 | 1.9 |
| Wound complication | 2.9 | 2.3 |
| Wound dehiscence | 1.3 | 1.5 |
| Wound secretion | 1.9 | 2.1 |
| Dysuria | 1.1 | 1.3 |
| Atelectasis | 3.4 | 1.9 |
Additional adverse experiences that were reported in this prophylaxis study with Invanz, regardless of causality, with an incidence <1.0% and >0.5% within each body system are listed below:
Gastrointestinal Disorders: dry mouth, hematochezia;
General Disorders and Administration Site Condition: crepitations;
Infections and Infestations: abdominal abscess, fungal rash, pelvic abscess;
Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication;
Musculoskeletal and Connective Tissue Disorders: muscle spasms;
Nervous System Disorders: cerebrovascular accident;
Renal and Urinary Disorders: pollakiuria;
Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.
Pediatric Patients
Clinical studies enrolled 384 patients treated with ertapenem; in some of the clinical studies, parenteral therapy was followed by a switch to an appropriate oral antimicrobial. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 8 shows the incidence of adverse experiences reported in ≥1.0% of pediatric patients in clinical studies. The most common drug-related adverse experiences in pediatric patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), vomiting (2.1%).
| Invanz*† | Ceftriaxone* | Ticarcillin/ Clavulanate† | |
| Adverse Events | (N=384) | (N=100) | (N=24) |
|
|||
| Local: | |||
| Infusion Site Erythema | 3.9 | 3.0 | 8.3 |
| Infusion Site Induration | 1.0 | 1.0 | 0.0 |
| Infusion Site Pain | 7.0 | 4.0 | 20.8 |
| Infusion Site Phlebitis | 1.8 | 3.0 | 0.0 |
| Infusion Site Swelling | 1.8 | 1.0 | 4.2 |
| Infusion Site Warmth | 1.3 | 1.0 | 4.2 |
| Systemic: | |||
| Abdominal Pain | 4.7 | 3.0 | 4.2 |
| Upper Abdominal Pain | 1.0 | 2.0 | 0.0 |
| Constipation | 2.3 | 0.0 | 0.0 |
| Diarrhea | 11.7 | 17.0 | 4.2 |
| Loose Stools | 2.1 | 0.0 | 0.0 |
| Nausea | 1.6 | 0.0 | 0.0 |
| Vomiting | 10.2 | 11.0 | 8.3 |
| Pyrexia | 4.9 | 6.0 | 8.3 |
| Abdominal Abscess | 1.0 | 0.0 | 4.2 |
| Herpes Simplex | 1.0 | 1.0 | 4.2 |
| Nasopharyngitis | 1.6 | 6.0 | 0.0 |
| Upper Respiratory Tract Infection | 2.3 | 3.0 | 0.0 |
| Viral Pharyngitis | 1.0 | 0.0 | 0.0 |
| Hypothermia | 1.6 | 1.0 | 0.0 |
| Dizziness | 1.6 | 0.0 | 0.0 |
| Headache | 4.4 | 4.0 | 0.0 |
| Cough | 4.4 | 3.0 | 0.0 |
| Wheezing | 1.0 | 0.0 | 0.0 |
| Dermatitis | 1.0 | 1.0 | 0.0 |
| Pruritus | 1.6 | 0.0 | 0.0 |
| Diaper Dermatitis | 4.7 | 4.0 | 0.0 |
| Rash | 2.9 | 2.0 | 8.3 |
Additional adverse experiences that were reported with Invanz with an incidence <1.0% and >0.5% within each body system are listed below:
General Disorders and Administration Site Condition: chest pain, infusion site pruritus;
Infections and Infestations: candidiasis, ear infection, oral candidiasis;
Metabolism and Nutrition Disorders: decreased appetite;
Musculoskeletal and Connective Tissue Disorders: arthralgia;
Nervous System Disorders: somnolence;
Psychiatric Disorders: insomnia;
Reproductive System and Breast Disorders: genital rash;
Respiratory, Thoracic and Mediastinal Disorders: pleural effusion, rhinitis, rhinorrhea;
Skin and Subcutaneous Tissue Disorders: dermatitis atopic, rash erythematous, skin lesion;
Vascular Disorders: phlebitis.
Post-Marketing Experience:
The following post-marketing adverse experiences have been reported:
Immune System: anaphylaxis including anaphylactoid reactions
Psychiatric Disorders: altered mental status (including aggression, delirium)
Nervous System & Psychiatric: dyskinesia, hallucinations, myoclonus, tremor
Adverse Laboratory Changes
AdultsLaboratory adverse experiences that were reported during therapy in ≥1.0% of adult patients treated with Invanz in clinical studies are presented in Table 9. Drug-related laboratory adverse experiences that were reported during therapy in ≥1.0% of adult patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, in clinical studies were ALT increased (6.0%), AST increased (5.2%), serum alkaline phosphatase increased (3.4%), platelet count increased (2.8%), and eosinophils increased (1.1%). Ertapenem was discontinued due to laboratory adverse experiences in 0.3% of patients.
| Invanz† 1 g daily |
Piperacillin/ Tazobactam† 3.375 g q6h |
Invanz‡ 1 g daily |
Ceftriaxone‡ 1 or 2 g daily |
|
| Adverse laboratory experiences | (n§=766) | (n§=755) | (n§=1122) | (n§=920) |
|
||||
| ALT increased | 8.8 | 7.3 | 8.3 | 6.9 |
| AST increased | 8.4 | 8.3 | 7.1 | 6.5 |
| Serum albumin decreased | 1.7 | 1.5 | 0.9 | 1.6 |
| Serum alkaline phosphatase increased | 6.6 | 7.2 | 4.3 | 2.8 |
| Serum creatinine increased | 1.1 | 2.7 | 0.9 | 1.2 |
| Serum glucose increased | 1.2 | 2.3 | 1.7 | 2.0 |
| Serum potassium decreased | 1.7 | 2.8 | 1.8 | 2.4 |
| Serum potassium increased | 1.3 | 0.5 | 0.5 | 0.7 |
| Total serum bilirubin increased | 1.7 | 1.4 | 0.6 | 1.1 |
| Eosinophils increased | 1.1 | 1.1 | 2.1 | 1.8 |
| Hematocrit decreased | 3.0 | 2.9 | 3.4 | 2.4 |
| Hemoglobin decreased | 4.9 | 4.7 | 4.5 | 3.5 |
| Platelet count decreased | 1.1 | 1.2 | 1.1 | 1.0 |
| Platelet count increased | 6.5 | 6.3 | 4.3 | 3.5 |
| Segmented neutrophils decreased | 1.0 | 0.3 | 1.5 | 0.8 |
| Prothrombin time increased | 1.2 | 2.0 | 0.3 | 0.9 |
| WBC decreased | 0.8 | 0.7 | 1.5 | 1.4 |
| Urine RBCs increased | 2.5 | 2.9 | 1.1 | 1.0 |
| Urine WBCs increased | 2.5 | 3.2 | 1.6 | 1.1 |
Additional laboratory adverse experiences that were reported during therapy in >0.1% but <1.0% of patients treated with Invanz in clinical studies include: increases in BUN, direct and indirect serum bilirubin, serum sodium, monocytes, PTT, urine epithelial cells; decreases in serum bicarbonate.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with ertapenem, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.
In a clinical study in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of ertapenem 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall laboratory adverse experience profile was generally comparable to that observed for ertapenem in previous clinical trials. Additional laboratory adverse experiences that were reported during therapy and the 14 days post surgery period in >1.0% of patients, regardless of causality, include: white blood cell count increased and urine protein present.
Pediatric PatientsLaboratory adverse experiences that were reported during therapy in ≥1.0% of pediatric patients treated with Invanz in clinical studies are presented in Table 10. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with Invanz, including those who were switched to therapy with an oral antimicrobial, in clinical studies were neutrophil count decreased (3.0%), ALT increased (2.2%), and AST increased (2.1%).
| Invanz | Ceftriaxone | Ticarcillin/ Clavulanate |
|
| Adverse laboratory experiences | (n†=379) | (n†=97) | (n†=24) |
| ALT Increased | 3.8 | 1.1 | 4.3 |
| Alkaline Phosphatase Increased | 1.1 | 0.0 | 0.0 |
| AST Increased | 3.8 | 1.1 | 4.3 |
| Eosinophil Count Increased | 1.1 | 2.1 | 0.0 |
| Neutrophil Count Decreased | 5.8 | 3.1 | 0.0 |
| Platelet Count Increased | 1.3 | 0.0 | 8.7 |
Additional laboratory adverse experiences that were reported during therapy in >0.5% but <1.0% of patients treated with Invanz in clinical studies include: white blood cell count decreased and urine protein present.
TopSide Effects by Body System
General
In general, the most common side effects associated with ertapenem have been considered mild to moderate and have included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).
Side effects in pediatric patients were similar to those in adults, with the most common adverse reactions including diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), and vomiting (2.1%).
Local
Local side effects have included infused vein complication (up to 7.1%), extravasation (up to 1.9%), and phlebitis/thrombophlebitis (up to 1.9%). Side effects reported in more than 0.1% of patients have included injection site induration and injection site pain. Tenderness and ecchymosis have also been reported.
Nervous system
In clinical trials, seizures were reported in 0.5% of patients. Patients with end-stage renal disease may be at a greater risk of developing seizures. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of ertapenem.
Nervous system side effects have included headache (up to 6.8%), altered mental status (agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, and stupor; up to 5.1%), insomnia (3.2%), dizziness (up to 2.1%), anxiety (up to 1.4%), and asthenia/fatigue (1.2%). Side effects reported in more than 0.1% of patients have included nervousness, seizure, tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, and vertigo. Hallucinations have been reported during postmarketing experience.
Side effects reported in more than 0.5% and less than 1.0% of patients have included cerebrovascular accident in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Gastrointestinal
Gastrointestinal side effects have included diarrhea (up to 10.3%), nausea (up to 8.5%), abdominal pain (up to 4.3%), constipation (up to 4%), vomiting (up to 4%), acid regurgitation (up to 1.6%), dyspepsia (up to 1.1%), and oral candidiasis (up to 1.4%). Side effects reported in more than 0.1% of patients have included gastrointestinal hemorrhage, anorexia, flatulence, Clostridium difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis, and taste perversion.
Small intestinal obstruction (2.1%) and C difficile infection or colitis (1.7%) have been reported in a study using 1 gram dosage of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Side effects reported in more than 0.5% and less than 1.0% of patients have included dry mouth and hematochezia.
Cardiovascular
Cardiovascular side effects have included edema/swelling (up to 3.4%), chest pain (up to 1.5%), hypotension (up to 2%), hypertension (up to 1.6%), and tachycardia (up to 1.6%). Side effects reported in more than 0.1% of patients have included syncope, heart failure, hematoma, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, and subdural hemorrhage.
Respiratory
Respiratory side effects have included dyspnea (up to 2.6%), cough (up to 1.6%), pharyngitis (up to 1.1%), rales/rhonchi (up to 1.1%), and respiratory distress (up to 1%). Side effects reported in more than 0.1% of patients have included pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, and voice disturbance.
Pneumonia (2.1%) and atelectasis (3.4%) have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Side effects reported in more than 0.5% and less than 1.0% of patients have included lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing.
Dermatologic
Dermatologic side effects have included rash (up to 2.5%), pruritus (up to 2%), and erythema (up to 1.6%). Side effects reported in more than 0.1% of patients have included sweating, dermatitis, desquamation, flushing, and urticaria.
Cellulitis (1.5%) has been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Hematologic
Hematologic side effects have included increased platelet count (up to 6.5%), decreased hemoglobin (up to 4.9%), decreased hematocrit (up to 3.4%), increased eosinophils (up to 2.1%), decreased segmented neutrophils (up to 1.5%), increased prothrombin time (up to 1.2%), decreased platelet count (1.1%), and decreased WBCs (up to 1.5%). Side effects reported in more than 0.1% of patients have included increased monocytes and PTT.
Anemia (5.7%) and increased WBCs have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Genitourinary
Genitourinary side effects have included vaginitis (up to 3.3%), increased urine RBCs (up to 2.5%), and increased urine WBCs (up to 2.5%). Side effects reported in more than 0.1% of patients have included vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis, and increased urine epithelial cells.
Urinary tract infection (3.8%) and dysuria (1.1%) have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Other
In clinical trials, death occurred in 1.6% of all patients (n=1954). In patients with intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving ertapenem; however, these were considered not drug-related.
Side effects affecting the body as a whole have included fever (up to 5%) and death (up to 2.5%). Side effects reported in more than 0.1% of patients have included abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, necrosis, candidiasis, weight loss, facial edema, and flank pain.
Postoperative infection (2.3%), wound infection (6.5%), anastomotic leak (1.5%), seroma (1.3%), wound complication (2.9%), wound dehiscence (1.3%), and wound secretion (1.9%) have been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Side effects reported in more than 0.5% and less than 1.0% of patients have included crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication.
Musculoskeletal
Musculoskeletal side effects have included leg pain (up to 1.1%).
Side effects reported in more than 0.5% and less than 1.0% of patients have included muscle spasms in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Hepatic
Hepatic side effects have included increased ALT (up to 8.8%), AST (up to 8.4%), and alkaline phosphatase (up to 6.6%).
Metabolic
Metabolic side effects have included decreased serum potassium (up to 1.8%), decreased serum albumin (up to 1.7%), increased serum glucose (up to 1.7%), increased serum bilirubin (up to 1.7%), and increased serum potassium (up to 1.3%). Side effects reported in more than 0.1% of patients have included increased BUN, increased direct and indirect serum bilirubin, increased serum sodium, and decreased serum bicarbonate.
Increased urine protein has been reported in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Renal
Renal side effects have included increased serum creatinine (up to 1.1%). Side effects reported in more than 0.1% of patients have included renal insufficiency and oliguria/anuria.
Side effects reported in more than 0.5% and less than 1.0% of patients have included pollakiuria in a study using 1 gram of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.
Hypersensitivity
Hypersensitivity reactions have included postmarketing reports of anaphylaxis and anaphylactoid reactions.
Top
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